Editors' Desk
-
The Enlightened Battles Of Biopharma Outsourcing
3/1/2016
In drug development, the threat level is always immanent. Too often there’s no alternative to preparing a detailed map of a landscape that may not exist. “Outsourcing” is the inadequate label we’ve affixed to a potent weapon to more effectively wage winning campaigns.
-
Biopharma Outsourcing Past Is Prologue
2/24/2016
It seems the more things change, the more these three components – biopharma entrepreneurs, financial backers, and outsourcing service providers – need to work together. The past helps us see this future more clearly.
-
Insiders’ Guide To Winning In The Drug Delivery Device Market — Part 4: Vertical Integration
2/23/2016
The tenets of vertical integration can drive a complete combination product development strategy, as well as establish the internal core competencies needed to consistently execute that strategy. I recently sat down with Anand Subramony, VP of drug delivery and device development at Medimmune (the global biologics arm of AstraZeneca). We discussed his thoughts on trends in the drug delivery device market and how the business philosophies of vertical integration can play a role.
-
Biopharma Climbs The Serialization Mountain
2/11/2016
The data associated with drug-product serialization will be Everest-like; accessing it may pose every bit the security risk. The difference is millions of people may be trying to access the summit … every day. What’s clear today is that a national program for drug serialization looms large on the horizon, and rises, if you will, high into the data clouds.
-
Insiders’ Guide To Winning In the Drug Delivery Device Market — Part 3: Quality Systems
2/9/2016
I recently sat down with Christopher Eustace of Hospira, who has over 27 years of quality experience in both the pharmaceutical and medical device industries, to discuss how a combined QS program is necessary for life science companies striving to capture their piece of the delivery device market.
-
Drug Serialization Reaching Consumers
2/8/2016
Three years into a U.S. initiative for drug “serialization,” companies are: (a) working with the FDA; (b) taking their own steps to traceability; and/or (c) hoping the day of reckoning fades further into the future. But the future is here with serialization reaching into the consumer’s home.
-
Is Marketing Manipulating Your CMO Selection?
2/2/2016
A report on biologics API outsourcing provides insights on how marketing and reputation influences BioPharma's selection of CMOs. Both sides need to line up actual CMO performance and capabilities with market perceptions. But sponsors beware: Under a marketing spell, it appears the best strategy to select CMOs is to find those perceived as most expensive.
-
UPS Pain In The Chain Survey: Pharma Makes Gains In Compliance, Partnerships
2/1/2016
UPS' Pain in the Chain survey is one of the best ways to understand where life science companies stand on the issues making logistics a headache and keeping executives up at night. Since 2008, the survey of healthcare and life science supply chain professionals has attempted to determine the needs of these companies.
-
Insiders’ Guide To Winning In the Drug Delivery Device Market — Part 2: Regulatory Compliance
1/26/2016
I recently sat down with David Amor, managing partner at MEDgineering, Inc., to discuss the challenges associated with bringing drug delivery devices to market, as well as emerging therapeutic areas and technologies. David’s background is in mechanical and biomedical engineering, with expertise in regulatory systems and compliance.
-
More Biotech Mixology For Successful Outsourcing
1/25/2016
Last we left off, M. (Ken) Kengatharan, PhD, MBA, serial start-up entrepreneur and scientist – or biotech mixologist – was mixing examples of outsourcing that included falsely inflated balloons and Super Hero deliveries of API. Here Kengatharan draws some final lessons and insights into successful outsourcing.